Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

BACKGROUND: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. DISCUSSION: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice. TRIAL REGISTRATION: NCT 02514538.

[What do men between 50 and 70 know about the effectiveness, the benefits, and the risks of prostate cancer screening?]. / Conocen los varones de 50-70 años la efectividad, los beneficios y los riesgos del cribado del cáncer de próstata?

OBJECTIVE: To evaluate the understanding of the population on prostate cancer screening. DESIGN: Descriptive study. SETTING: Primary care teams in the province of Barcelona, Spain, from april to september 2005. PARTICIPANTS AND CONTEXT: Men between 50 and 70 years old without prostate symptoms and seen in the clinics of 12 primary care teams. METHOD: Systematic sample. VARIABLES: age, marital status, educational level, and self-perceived health status. Appraisal of knowledge through a 14-question questionnaire referring to the key ideas, previously defined by a group of experts, requisite before deciding on prostate cancer screening. RESULTS: N=221. Mean age, 59.9 (SD, 5.9); educational level, primary or lower: 63.4%; 89.1% (95% CI, 84.4-92.6) did not have sufficient knowledge about prostate cancer screening. In the questions on what PSA is and what it is for, over 50% said they did not know; 63.3% recognised that prostate cancer was a highly prevalent illness; 84.6% replied that early detection of prostate cancer avoids deaths; 49.8% did not know whether the doctor had doubts on this question; and 38.9% thought he didn't. There were no differences in knowledge for any of the variables studied. CONCLUSIONS: Although prostate cancer screening is widely known about, the information of the population is scant and often wrong. Existing scientific uncertainty on the use of screening is the aspect that is least known by users.